High Dose Vitamin B1 to Reduce Abusive Alcohol Use - Full Text View

Sponsors and Collaborators:	University of Kansas Hanlon Trust
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00680121

Purpose

B1AS tests the hypothesis that increased vitamin B1 (thiamine) intake can repair brain systems damaged by alcohol and help people with alcohol problems control their alcohol use. A strong, man-made form of thiamine (Benfotiamine) is used to increase blood thiamine to much higher levels than can be achieved using normal vitamin supplements. Drinking patterns are examined over 6 months of continued supplement use. Men and women with a recent history of alcohol problems are eligible to participate.

Condition	Intervention	Phase
Alcoholism	Drug: Benfotiamine Drug: Placebo	Phase IV

MedlinePlus related topics: Alcohol Alcoholism

Drug Information available for: Thiamine Thiamine hydrochloride Benfotiamine Thiamine nitrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effectiveness of Benfotiamine in Reducing Abusive Drinking Among Family History Positive and Negative Alcoholics

Further study details as provided by University of Kansas:

Primary Outcome Measures:

Days of drinking [ Time Frame: 1 and 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Drinking severity scale, Barrett Impulsivity Scale, Breathalyzer Positive Tests, SCL-90 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	July 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: Placebo Placebo
2: Experimental Benfotiamine 600 mg	Drug: Benfotiamine Benfotiamine 600 mg

Detailed Description:

B1AS is a randomized, double-blind placebo-controlled clinical trial of the effectiveness of Benfotiamine at reducing abusive drinking patterns in individuals with recent alcohol problems. Subjects consume 4 tablets of Benfotiamine (600 mg) or placebo daily for 6 months. Monthly follow-ups track alcohol use and alcohol-related problems over the 6 months. Blood tests are also conducted to determine the frequency of an inherited abnormality in thiamine processing that may be related to the risk of developing alcoholism.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Problem drinking in the last 30 days

Exclusion Criteria:

Prolonged abstinence
Serious medical problems

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680121

Contacts

Contact: Marilyn Logan

913-588-1315

Locations

United States, Kansas
University of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States, 66160
Contact: Marilyn Logan 913-588-1315

Sponsors and Collaborators

University of Kansas

Hanlon Trust

Investigators

Principal Investigator:

Ann Manzardo, PhD

University of Kansas

More Information

No publications provided

Responsible Party:	University of Kansas Medical Center, Psychiatry and Behavioral Sciences ( Ann Manzardo PhD )
Study ID Numbers:	11236
Study First Received:	May 15, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00680121 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Kansas:

Alcoholism
Benfotiamine
Thiamine

Study placed in the following topic categories:

Vitamin B Complex
Immunologic Factors
Thiamine
Adjuvants, Immunologic
Disorders of Environmental Origin
Trace Elements
Alcohol Drinking
Benphothiamine

Mental Disorders
Vitamins
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Micronutrients
Chelating Agents
Ethanol

Additional relevant MeSH terms:

Vitamin B Complex
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Thiamine
Adjuvants, Immunologic
Disorders of Environmental Origin
Pharmacologic Actions

Benphothiamine
Mental Disorders
Vitamins
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Micronutrients
Chelating Agents

ClinicalTrials.gov processed this record on May 07, 2009